AccessGUDID - DEVICE: Oxygen Delivery Adapter for T-HME (00848530062354)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Delivery Adapter for T-HME
Version or Model: RES027A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES027A
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530062354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Oxygen Delivery Adapter for T-HME (1/pack)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42988	Low-pressure tubing connector, reusable	A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 800cc

Device Record Status

Public Device Record Key: d857f0cf-63fe-414a-9062-49858f09bc1e
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018